(111 days)
The ZZOMA Positional Sleeper is indicated for use and intended for professional use for the treatment of mild to moderate, predominantly positional obstructive sleep apnea (OSA) and to reduce or alleviate snoring.
The ZZOMA Positional Sleeper is intended for use by professional healthcare personnel trained in its use.
The ZZOMA Positional Sleeper is 12 x 5.5 x 4 inches in size and made of lightweight semi-rigid synthetic foam (Figures 1 and 2). It is contained in a backpack type material with an associated Velcro® elastic belt. The device is worn on the back, with the elastic belts brought around each side of the subject and secured anteriorly with the adjustable straps. The particular size and wedge-shaped design on both sides of this device keeps the subject comfortably positioned on their side, and prevents him/her from assuming the supine position. The ZZOMA has a firm inner core made of foam and the outer part of the device is covered in nylon, and the part that touches the subject's body is cotton covered with a coating of PVC dots that help keep the ZZOMA in place while you sleep.
Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state formal "acceptance criteria" for the device, and the direct performance metrics are relative to CPAP therapy. However, the primary objective of the study can be interpreted as the functional "acceptance criteria" for the device's effectiveness.
| Acceptance Criteria (Inferred from Study Objective) | Reported Device Performance (ZZOMA Positional Sleeper) |
|---|---|
| Non-inferiority to CPAP therapy on the apnea-hypopnea index (AHI) after one night of therapy in patients with positional obstructive sleep apnea (OSA). | In patients with positional OSA, positional therapy is equivalent to CPAP therapy at normalizing the AHI, in addition to decreasing the AHI by >30%. |
| Ability to maintain the patient in the lateral position during sleep. | Similar to CPAP therapy in regards to effects on sleep quality and nocturnal oxygenation. |
| Initial effects on AHI and sleep quality comparable to CPAP therapy. | There is no significant difference between positional therapy and CPAP therapy at maintaining patients in the non-supine position throughout the night. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The text states, "There were 4 major findings in this study: 7/11 patients with positional OSA...". This indicates the study involved 11 patients with positional OSA.
- Data Provenance: The text does not specify the country of origin of the data. The study was conducted to examine the non-inferiority of the device, which typically implies a prospective clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The text does not provide information on the number of experts used or their qualifications for establishing the ground truth. It mentions a "clinical study" but doesn't detail the methodology for expert
review or assessment of sleep parameters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The text does not provide information on any adjudication method used for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable as the device is a physical positional sleeper for OSA, not an AI-assisted diagnostic or interpretive tool that would involve human "readers." The study compares the device's effectiveness to CPAP therapy, not to human interpretation with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The ZZOMA Positional Sleeper is a physical device, not an algorithm. Its performance is measured directly by its physiological impact on the patient during sleep.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth or primary outcome measure for the study was the apnea-hypopnea index (AHI) and the patient's sleep position, which are objective physiological measurements obtained during sleep studies. This falls under outcomes data or physiological measurements.
8. The sample size for the training set
The text does not provide information on a "training set" as this is a physical device being evaluated in a clinical trial, not a machine learning algorithm.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as #8.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”